Verigene Clostridium difficile Nucleic Acid Test Kit recall
Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
Why was Verigene Clostridium difficile Nucleic Acid Test Kit recalled?
Potential for a false-negative result.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
041520022A, 061920022A, and 081120022A
- Product
- Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
- Recalling firm
- Luminex Corporation
- Quantity
- 1,261
- Distribution
- Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.
- Recall date
- July 14, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)